Page 18 - Terminology-Clinical-Research

DHHS: Department of Health and Human Services (or Disease control rate (DCR): Percentage of patients whose
HHS). cancer shrinks or remains stable over a certain time period.
DCR is the sum of the complete, partial and stable disease
Diagnosis: The determination of the nature of a case of rates. Also known as clinical benefit rate (CBR).
disease; the art of distinguishing one disease from another.
Disease/recurrence free survival (DFS): Length of time
Diagnostic trials: Refers to trials that are conducted to find after treatment that a patient survives with no sign of
better tests or procedures for diagnosing a particular disease disease.
or condition. Diagnostic trials usually include people who
have signs or symptoms of the disease or condition being Disease: Any deviation from or interruption of the normal
studied. structure or function of a part, organ, or system of the body
as manifested by characteristic symptoms and signs.
Digital signature: An electronic signature, based on
cryptographic methods of originator authentication, Dissemination: Dissemination involves identifying the
computed by using a set of rules and a set of parameters, appropriate audience and tailoring the message and medium
such that the identity of the signer and the integrity of the to the audience. Dissemination activities can include
data can be verified. such things as summaries for / briefings to stakeholders,
educational sessions with patients, practitioners and/or
Direct access: Permission to examine, analyze, verify, and policy makers, engaging knowledge users in developing
reproduce any records and reports that are important to and executing dissemination/implementation plan, tools
evaluation of a clinical trial. Note: The party (e.g., domestic creation, and media engagement.
and foreign regulatory authorities, sponsor’s monitors
and auditors) with direct access should take all reasonable Distant disease/recurrence free survival (DDFS): Length
precautions within the constraints of the applicable of time after treatment that a patient survives with no
regulatory requirement(s) to maintain the confidentiality of sign of disease in a different part of the body to the site
subjects’ identities and sponsor’s proprietary information. the disease was originally treated (i.e. time without the
emergence of new metastases - the spread of a disease from
Direct entry: Recording of data by human or automated one organ or part of the body to another non-adjacent organ
action where an electronic record is the original means of or part).
capturing the data into an electronic records system without
a paper source document. Examples are an individual Distribution: 1. In statistics, a group of ordered values; the
keying original observations into a system or the automatic frequencies or relative frequencies of all possible values of
recording into the system of the output from measuring a characteristic. 2. In pharmacokinetics, the processes that
devices such as a balance that measures subject’s body control transfer of a drug from the site of measurement to
weight or an ECG machine. its target and other tissues.

Discontinuation: The act of concluding participation, Document (HL7): An ordered presentation of XML
prior to completion of all protocol-required elements, elements, possibly including text and tabular analyses,
in a trial by an enrolled subject. Note: Four categories description, and figures. Descriptors for HL7 documents
of discontinuation are distinguished: a) dropout: Active include type, class, and element. Note: In HL7, a document
discontinuation by a subject (also a noun referring to can be either physical (referring to the paper) or logical
such a discontinued subject); b) investigator initiated (referring to the content) with the following characteristics:
discontinuation (e.g., for cause); c) loss to follow-up: 1) Stewardship; 2) Potential for authentication;
cessation of participation without notice or action by
the subject; d) sponsor initiated discontinuation. Note 3) Wholeness; 4) Human readability; 5) Persistence; 6)
that subject discontinuation does not necessarily imply Global vs. local context.
exclusion of subject data from analysis. “Termination” Document root: The element in an XML document
has a history of synonymous use, but is now considered that contains all other elements; the first element in the
nonstandard.
document.
Discrepancy: The failure of a data point to pass a
validation check. Note: Discrepancies may be detected by Document type definition (DTD): XML specification for
content and presentation of data and text in a document
computerized edit checks or observed/identified by the data including definitions for the elements considered to be
reviewer as a result of manual data review.

18 AlphaScienceLabs.com